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Serving 500+ biopharmaceutical companies globally:

Chubb
US Department of Justice
Cerilliant
AstraZeneca
Covington
Farmers Insurance
Accenture
Cipla
McKinsey
Colorcon

Generated: September 25, 2017

DrugPatentWatch Database Preview

GLAXOSMITHKLINE Company Profile

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What is the competitive landscape for GLAXOSMITHKLINE, and what generic alternatives to GLAXOSMITHKLINE drugs are available?

GLAXOSMITHKLINE has one hundred and fifty-nine approved drugs.

There are fifty-seven US patents protecting GLAXOSMITHKLINE drugs.

There are one thousand one hundred and twenty-five patent family members on GLAXOSMITHKLINE drugs in sixty-nine countries.

Summary for Applicant: GLAXOSMITHKLINE

Patents:57
Tradenames:113
Ingredients:95
NDAs:159
Drug Master File Entries: (click here to view)8
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc
RYTHMOL SR
propafenone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021416-001Sep 4, 2003ABRXYesNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline
ABREVA
docosanol
CREAM;TOPICAL020941-001Jul 25, 2000OTCYesYes► Subscribe► Subscribe► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-001Aug 20, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
IMITREX
sumatriptan
SPRAY;NASAL020626-003Aug 26, 1997ABRXYesYes► Subscribe► Subscribe► Subscribe
Glaxosmithkline
TRITEC
ranitidine bismuth citrate
TABLET;ORAL020559-001Aug 8, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Cons
EXCEDRIN (MIGRAINE)
acetaminophen; aspirin; caffeine
TABLET;ORAL020802-001Jan 14, 1998OTCYesYes► Subscribe► Subscribe ► Subscribe
Glaxosmithkline
NIX
permethrin
LOTION;TOPICAL019435-001Mar 31, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-002May 18, 2009OTCYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
ARNUITY ELLIPTA
fluticasone furoate
POWDER;INHALATION205625-002Aug 20, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Glaxosmithkline
THORAZINE
chlorpromazine hydrochloride
TABLET;ORAL009149-013Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Glaxosmithkline

Paragraph IV activity for GLAXOSMITHKLINE drugs

Drugname Dosage Strength Tradename Submissiondate
lamotrigine
Extended-release Tablets25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg
LAMICTAL XR
2/12/2014
nicotine polacrilex
Gum2 mg
NICORETTE
1/22/2013
nicotine polacrilex
Gum4 mg
NICORETTE
1/22/2013
dutasteride and tamsulosin hydrochloride
Capsule0.5 mg/0.4 mg
JALYN
10/26/2010
atovaquone and proguanil hydrochloride
Tablets62.5 mg/25 mg
MALARONE
9/14/2010
orlistat
Capsules60 mg
ALLI
9/8/2010
lamotrigine
Orally Disintegrating Tablets25 mg, 50 mg, 100 mg, and 200 mg
LAMICTAL ODT
12/21/2009
atovaquone
Oral Suspension750 mg/5 mL
MEPRON
10/20/2009
ropinirole hydrochloride
Extended-release Tablets6 mg
REQUIP XL
7/22/2009
atovaquone and proguanil hydrochloride
Tablets250 mg/100 mg
MALARONE
4/3/2009
ropinirole hydrochloride
Extended-release Tablets12 mg
REQUIP XL
2/5/2009
ropinirole hydrochloride*
Extended-release Tablets3 mg
REQUIP XL
1/8/2009
ropinirole hydrochloride
Extended-release Tablets3 mg
REQUIP XL
1/8/2009
ropinirole hydrochloride
Extended-release Tablets8 mg
REQUIP XL
11/3/2008
ropinirole hydrochloride
Extended-release Tablets4 mg
REQUIP XL
10/31/2008
ropinirole hydrochloride
Extended-release Tablets2 mg
REQUIP XL
10/14/2008
lamivudine
Tablets100 mg
EPIVIR-HBV
10/31/2007
ranitidine hydrochloride
Tablets150 mg
ZANTAC 150
10/30/2007
dutasteride
Capsules0.5 mg
AVODART
10/29/2007
propafenone
Extended-release Capsules325 mg
RYTHMOL SR
11/7/2006
propafenone hydrochloride
Extended-release Capsules225 mg and 425 mg
RYTHMOL SR
10/11/2006
sumatriptan succinate
Injection6 mg/0.5 mL, 0.5 mL (prefilled syringes)
IMITREX
5/9/2006
ropinirole hydrochloride
Tablets3 mg, 4 mg and 5 mg
REQUIP
2/4/2005
ropinirole hydrochloride
Tablets0.25 mg, 0.5 mg, 1 mg and 2 mg
REQUIP
12/22/2004
sumatriptan succinate
Injection6 mg/0.5 mL, 0.5 mL vials
IMITREX
10/25/2004

Non-Orange Book Patents for Glaxosmithkline

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,198,483Phenethanolamine derivatives for treatment of respiratory diseases► Subscribe
8,575,347Muscarinic acetylcholine receptor antagonists► Subscribe
8,460,706Hydrophilic/lipophilic polymeric matrix dosage formulation► Subscribe
7,132,532Compounds useful in the manufacture of an anti-inflammatory androstane derivative► Subscribe
6,759,398 Anti-inflammatory androstane derivative► Subscribe
2,006,107,948► Subscribe
8,658,200Flavoring of drug-containing chewing gums► Subscribe
7,531,528Formulation containing anti-inflammatory androstane derivatives► Subscribe
6,792,945 Inhalation device► Subscribe
7,225,808Inhalation device► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Glaxosmithkline Drugs

Country Document Number Estimated Expiration
Norway338929► Subscribe
Iceland2268► Subscribe
Australia2003207016► Subscribe
TaiwanI363759► Subscribe
South Africa200209226► Subscribe
United Kingdom9501127► Subscribe
JapanH04220266► Subscribe
New Zealand534152► Subscribe
Poland167736► Subscribe
Iceland3873► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Glaxosmithkline Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2007Austria► SubscribePRODUCT NAME: DOCOSANOL; NAT. REGISTRATION NO/DATE: 1-27014 20070518; FIRST REGISTRATION: SE 18517 20031114
/2000Austria► SubscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
4 50004-2014Slovakia► SubscribePRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
80018Netherlands► SubscribePRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
C/GB98/019United Kingdom► SubscribePRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
12/2008Austria► SubscribePRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE
0140032 00132Estonia► SubscribePRODUCT NAME: UMEKLIDIINBROMIID;REG NO/DATE: EU/1/14/922 30.04.2014
C0025Belgium► SubscribePRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
C0042Belgium► SubscribePRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cerilliant
Fuji
Chinese Patent Office
Chubb
McKinsey
Accenture
Medtronic
Johnson and Johnson
Teva
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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ISSN: 2162-2639

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